Handheld blood glucose monitoring device with messaging capability

ABSTRACT

A patient monitoring network pertaining to blood glucose and other analyte measurements includes wireless blood glucose or other analyte measuring devices and a networked computer or server. Each monitoring device is associated with a patient and is configured to measure the glucose level or other analyte from a given blood sample via inserted test strips, transmit the measurements to the networked computer, and display received messages. The blood glucose monitoring device includes means for substantially reducing factors that could affect the glucose measurement such as thermal and RF interference.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/621,656, filed Sep. 17, 2012, which is a continuation of U.S. patentapplication Ser. No. 13/364,130, filed Feb. 1, 2012, which is acontinuation-in-part of U.S. patent application Ser. No. 13/293,046,filed Nov. 9, 2011, each of which is incorporated herein by reference inits entirety.

BACKGROUND

Field of the Invention

The invention relates to wireless medical devices for collectinginformation from patients at remote locations and, more particularly, tohandheld glucose monitoring devices for wirelessly communicating bloodglucose and other analyte readings from patients to a remote server andfor communicating related information from the server back to thepatients.

Background

Diabetes is a metabolic disease in which a person has high blood sugareither due to the body's inability to produce insulin, or the cellsinability to respond to insulin. The disease can cause numerouscomplications, both short-term and long-term, and ultimately death ifnot well treated. Diabetes is the seventh leading cause of death in theUnited States by disease with nearly 284,000 deaths reported in 2007.

Medical expenditures on those living with diabetes in the United Stateshave steadily increased every year. People with diabetes have medicalcosts that are nearly 2.5 times higher than those without the disease.From 1980 through 2007, the number of Americans with diabetes quadrupledfrom 5.6 million to 23.6 million, accounting for 8% of the total U. S.population. Based on these numbers, the U.S. has spent over 174 billiondollars on caring for those diagnosed with diabetes in 2007 alone, afigure that makes up nearly 40% of the worldwide cost for treatingdiabetes. U.S. spending on diabetes is expected to rise to over 336billion dollars by the year 2034.

One of the factors leading to high costs for diabetes treatment is theissue of patient non-compliance. It is vital that patients diagnosedwith diabetes regularly measure their blood glucose levels throughoutthe day and self-administer insulin injections if necessary. Failure todo so can lead to more hospitalizations and potentially create furtherhealth problems, all of which increase medical costs. On average, theannual medical costs per patient are nearly 3000 dollars higher fornon-compliant patients versus those who regularly track their bloodglucose levels. It is therefore an important initiative to improve thelevel of patient compliance as it pertains to effective treatment fordiabetes.

Current treatment protocols and methods rely entirely on theself-motivation of the patient to measure and record the results oftheir blood glucose levels which requires a high level of individualattention.

What is needed is a treatment protocol that improves patient complianceand improves treatment by facilitating real-time communication to andfrom the patient.

SUMMARY

In an embodiment, a handheld blood glucose monitoring device isdescribed. The device includes a glucose sensing subsystem, a radiotransceiver subsystem, and a display. The glucose sensing subsystem isconfigured to measure a blood glucose level in a blood sample. The radiotransceiver subsystem is configured to receive blood glucosemeasurements from the glucose sensing subsystem, to transmit the bloodglucose measurements over a wireless communications link, and to receiveover the wireless communications link a message returned to the handhelddevice in response to the transmitted blood glucose measurement. Thedisplay is configured to display blood glucose measurements from theglucose sensing subsystem and to display the message received from theradio transceiver subsystem. The device further includes means forsubstantially reducing RF interference caused by the radio transceiversubsystem, and means for mitigating the effects of heat generated by thedevice on a temperature sensor coupled to the device.

In an alternate embodiment, the handheld monitoring device can be usedto monitor other analytes. For, example, the blood glucose sensor may bereplaced with a sensor to monitor interstitial fluid glucose, bloodcoagulation factors, cardiac enzymes, catecholamines, and otherbiomarkers. Such alternate sensors may operate, for example, usingelectrochemical or colorimetric sensing techniques as would be apparentto a person skilled in the relevant art.

In this alternate embodiment, similar to the blood glucose monitoringdevice, the handheld analyte monitoring device includes an analytesensing subsystem configured to measure an analyte from a patient, and aradio transceiver subsystem configured to receive analyte measurementsfrom the analyte sensing subsystem and to transmit the analytemeasurements over a wireless communications link. Similar to the bloodglucose monitoring system, the handheld analyte monitoring devicefurther includes means for substantially reducing RF interference causedby the radio transceiver subsystem, and means for mitigating the effectsof heat generated by the device on a temperature sensor coupled to thedevice.

Another embodiment of the invention includes a test strip for receivinga liquid sample, which may be used in either the glucose monitoringdevice or the analyte monitoring device. The test strip includes areservoir channel for receiving the liquid sample, one or moremeasurement electrodes disposed within the reservoir channel, one ormore contact electrodes, and a temperature sensor disposed substantiallyat or near the one or more measurement electrodes. The test stripfurther includes means for electrically coupling the measurementelectrodes to the contact electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate embodiments of the present inventionand, together with the description, further serve to explain theprinciples of the invention and to enable a person skilled in thepertinent art to make and use the invention.

FIG. 1 illustrates a patient monitoring network, according to anembodiment.

FIG. 2 illustrates an embodiment of a blood glucose monitoring device.

FIG. 3 illustrates a subsystem diagram of a blood glucose monitoringdevice, according to an embodiment.

FIG. 4 illustrates a state transition diagram of a blood glucosemonitoring device, according to an embodiment.

FIG. 5 illustrates a screenshot of a glucose data summary, according toan embodiment.

FIG. 6 illustrates a screenshot of a clinical profile, according to anembodiment.

FIG. 7 illustrates a screenshot of a data summary on a plurality ofpatients, according to an embodiment.

FIG. 8 illustrates a screenshot of a script editor, according to anembodiment.

FIG. 9 is a diagram illustrating a method performed by a blood glucosemonitoring device, according to an embodiment.

FIG. 10 is a diagram illustrating a method performed by a networkedcomputer, according to an embodiment.

FIG. 11 is a diagram illustrating a method performed by a blood glucosemonitoring device, according to an embodiment.

FIG. 12 is an example computer system in which the embodiments, orportions thereof, can be implemented as computer-readable code.

FIG. 13 is an illustration of a test strip, according to an embodiment.

DETAILED DESCRIPTION

Although specific configurations and arrangements are discussed, itshould be understood that this is done for illustrative purposes only. Aperson skilled in the pertinent art will recognize that otherconfigurations and arrangements can be used without departing from thespirit and scope of the present invention. It will be apparent to aperson skilled in the pertinent art that this invention can also beemployed in a variety of other applications beyond diabetes care.

It is noted that references in the specification to “one embodiment,”“an embodiment,” “an example embodiment,” etc., indicate that theembodiment described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesdo not necessarily refer to the same embodiment. Further, when aparticular feature, structure or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect such feature, structure or characteristicin connection with other embodiments whether or not explicitlydescribed.

FIG. 1 illustrates an exemplary patient monitoring system or network 100according to an embodiment. Patient monitoring network 100 includes aplurality of n blood glucose monitoring devices 104-1 to 104-n, eachassociated with a respective patient 102-1 to 102-n. Patient monitoringnetwork 100 further includes a networked computer 112 and a remotecomputer 114. In an embodiment, each blood glucose monitoring device104-1 to 104-n communicates wirelessly to a cellular telephone tower 108(“cell tower 108”) via a respective wireless communications link 106-1to 106-n. In an embodiment, cell tower 108 communicates with networkedcomputer 112 via communications link 110, and remote computer 114communicates with networked computer 112 via communications link 116.Communication links 110 and 116 can include any network or combinationof networks including, for example, the global Internet, a wide areanetwork (WAN), metropolitan area network (MAN), wireless network,telephone network, or local area network (LAN).

Networked computer 112 may include, for example, one or more standalonecomputers, a server, a virtual server, a server farm, or acloud-computing server. In an embodiment, wireless communications link106 may use any transmission means, or combination thereof, known to aperson skilled in the art which include, for example, WiFi, Bluetooth,satellite, 2G cellular, 3G cellular, 4G cellular, etc. In one preferredembodiment, communications link 106 includes 3G cellular communications.

A patient using a blood glucose monitoring device 104 within patientmonitoring network 100 may use device 104 to take a reading (i.e., ameasurement) of their blood glucose level from a blood sample. Themeasurement can be transmitted to networked computer 112, where themeasurement is stored in a record of a database. Each stored record isassociated with a particular patient.

In an embodiment, the blood glucose monitoring device 104 can alsoreceive one or more messages transmitted from the networked computer112. In an embodiment, blood glucose monitoring device 104 receives amessage as a result of transmitting a glucose reading to networkedcomputer 112. The received one or more messages may contain informationrelating to the most recent blood glucose measurement, informationrelating to past blood glucose measurements, and/or one or morepersonalized messages for the particular patient associated with theblood glucose monitoring device. In another example, networked computer112 tracks the number of glucose test strips used by the patient (basedon, for example, the number of blood-glucose measurements uploaded fromdevice 104 to networked computer 112) and, when the number of teststrips remaining is low (e.g., determined, for example, by comparing thenumber of measurements to a threshold value), transmits a low-supplymessage to blood glucose monitoring device 104, thereby alerting thepatient to order more test strips. In addition, the patient may useblood glucose monitoring device 104 to transmit a response to the one ormore messages back to networked computer 112. The response may include,for example, an order for more test strips. Test strip usage trackingand replacement strip ordering is discussed in more detail below.

One or more of the records (e.g., an authorized subset of records)stored on the database of networked computer 112 may be accessed viaremote computer 114. Remote computer 114 may be any device capable ofaccessing and displaying the records stored on the database of networkedcomputer 112 including, but not limited to, a smartphone, a computer(e.g., a personal computer or PC), a tablet PC, etc. In an embodiment, apatient may use remote computer 112 to access their own record. Therecord may contain summaries of all of the patient's past blood glucosereadings in various graphical formats and can allow customization by thepatient as is explained in more detail below. In an embodiment, acaregiver may use remote computer 112 to access the records of all thepatients under supervision of the caregiver. The caregiver may haveaccess to graphical summaries and data lists of blood glucose readingsfor all of their patients. In an embodiment, the caregiver accesses ascript editor to allow for customization of messages to be transmittedto each blood glucose monitoring device 104 and when each message is tobe transmitted. The utility of the script editor is explained in moredetail below.

FIG. 2 depicts left-side, front-side and right-side views of anembodiment of a blood glucose monitoring device 104. Blood glucosemonitoring device 104 includes a display 202, a connection port 204, atest strip port 206, a power button 208, and a SIM card door 216. In anembodiment, blood glucose monitoring device 104 also includes a userinterface (e.g., to receive user input) which comprises buttons alongthe side of blood glucose monitoring device 104. The buttons may includean up button 210, an enter (or select) button 212 and a down button 214.In another embodiment, display 202 may be a touch-screen display (i.e.,a touch-sensitive display) to act as the user interface in lieu of or inaddition to buttons 210-214.

Display 202 may utilize any technology known to those skilled in theart, including, but not limited to, LCD, OLED, TFT LCD, etc. In anembodiment, display 202 is configured to show the most recent bloodglucose reading taken by blood glucose monitoring device 104. Display202 may also show a graphical indication of a comparison between themost recent blood glucose reading taken and a target blood glucoselevel. In an embodiment, display 202 shows any messages received fromnetworked computer 112.

Test strip port 206 allows for the insertion of a blood glucose teststrip. Blood glucose test strips are disposable strips used to collect asmall blood sample from a patient as is known by those skilled in theart. The test strip may contain chemicals which react with the glucosepresent in the blood and produce a calibrated current response curve toan applied voltage. The calibration curve is generated by calibratingeach manufactured test strip lot against known blood standards using alaboratory reference instrument, such as a Yellow Springs Instrument(YSI) glucose analyzer. This calibration curve is converted to acalibration code that is imprinted on the glucose test strip usingconductive ink in order to enable blood glucose monitoring device 104 toidentify the correct calibration curve to apply to the signal generatedby the test strip, according to an embodiment. A total of seven (7)calibration curves are stored inside the firmware of blood glucosemonitoring device 104, according to an embodiment. In one example,identification of code and selection of calibration curve is performedautomatically upon placing the test strip into test strip port 206, andno code number is displayed to the patient. Power button 208 may be anysuitable switch to turn the power on and off to the device including,but not limited to, a slider, a toggle switch, a push button, etc. Itshould be understood that although power button 208 is illustrated inFIG. 2 to be located on the side of blood glucose monitoring device 104,power button 208 may be located anywhere on blood glucose monitoringdevice 104.

SIM card door 216 may be used to protect a subscriber identity module(SIM) card placed therein. The use of SIM cards is well known to aperson skilled in the art. In an embodiment, the SIM card within bloodglucose monitoring device 104 allows unique identification of bloodglucose monitoring device 104 within patient monitoring network 100.

Each button associated with the user interface of blood glucosemonitoring device 104 allows the patient to provide input. For example,up button 210 and down button 214 may be used to scroll through menuoptions displayed on display 202, while enter button 212 allows for theselection of a particular menu option. In another example, up button 210and down button 214 may be used to scroll through answer options for amessage received from networked computer 112 and displayed on display202, while enter button 212 may be used to choose an answer option andexecute the transmission of the chosen answer option to networkedcomputer 112. In another example, the user interface may be utilized bythe patient to facilitate the ordering of more test strips uponreceiving a message alerting the patient to order more. It should beunderstood that although up button 210, enter button 212, and downbutton 214 are illustrated in FIG. 2 to be located on the side of bloodglucose monitoring device 104, each button may be located anywhere on,blood glucose monitoring device 104. Further, these three buttons may beimplemented as features of a touch-sensitive display.

The calibrated current response, produced from the reaction of glucosewithin a blood sample with the chemicals on the test strip, may besensitive to ambient environmental conditions. For example, thechemicals on the test strip may contain enzymes which react with theglucose in a blood sample. These enzymes have a reaction rate which isdependent upon the temperature. Thus, successful calibration may alsorequire knowledge of the temperature during the reaction. For thisreason, a temperature sensor may be utilized in conjunction with theblood glucose measurements.

However, there are challenges with the incorporation of a temperaturesensor in the embodied blood glucose monitoring device. Components ofthe blood glucose monitoring device, such as batteries, active circuitcomponents, and the display, will generate heat that can raise thetemperature readings of any temperature sensor placed in the sameenclosure. The test strip, however, may not be affected by the sameheat, since the test strip will typically be located right at theinterface between the monitoring device's housing and the exteriorenvironment (i.e., ambient temperature). This may result in thetemperature sensor indicating a temperature that is different from whatthe reaction on the test strip (i.e., at the electrochemical reactionsite) is actually experiencing.

One solution to this challenge is to locate the temperature sensorremotely from the device's various sources of thermal energy. Forexample, the temperature sensor may be disposed within the housing ofthe device 104 but may be thermally segregated from the componentsprimarily responsible for generating the heat that causes the thermalinterference. This may be accomplished by subdividing the housing intodifferent compartments and by providing ventilation openings in theouter walls to allow convection cooling of each compartment. In anembodiment shown in FIG. 2, a stalk 201 may be added to blood glucosemonitoring device 104 to provide an external probe away from the mainbody of the device. A temperature sensor 203 may be disposed at the endof stalk 201, allowing for measurement of the ambient air temperaturewhile minimizing thermal interference from the components of bloodglucose monitoring device 104.

In another embodiment, the temperature sensor may be disposed directlyon the test strip. FIG. 13 illustrates a test strip 1300 for use in amonitoring device such as, for example, blood glucose monitoring device104. Test strip 1300 includes a temperature sensor 1304 disposed on abody portion 1301 (e.g., a plastic substrate such as is commonly usedfor test strips), according to an embodiment. Test strip 1300 mayfurther include a reservoir channel 1302, measurement electrodes 1306,electrical leads 1308, and contact electrodes 1310, each disposed onbody portion 1301. A liquid sample, for example, blood, is placed onreservoir channel 1302 where it comes into contact with measurementelectrodes 1306. Then, when a voltage is applied across measurementelectrodes 1306 by, for example, blood glucose monitoring device 104, anelectrochemical reaction is produced at the measurement electrodes,generating a current based on the concentration of an analyte, forexample, glucose, within the liquid sample. The current is measured viacontact electrodes 1310 by a monitoring device such as, for Example,blood glucose monitoring device 104.

Temperature sensor 1304 may be placed substantially near to measurementelectrodes 1306, providing an accurate temperature reading at the siteof the electrochemical reaction. Temperature sensor 1304 may be anysensor known to those skilled in the art including, but not limited to,a thermocouple, a resistive sensor, etc. The resistive sensor mayinclude, for example, a metallic material with a resistance that varieswith temperature, or a semiconductor material with a resistance thatvaries with temperature. It should be understood that temperature sensor1304 may also be disposed at any location on test strip 1300.

The various electrodes illustrated in FIG. 13 are only an example ofpossible electrode arrangement on test strip 1300 and are not meant tobe limiting. Contact electrodes 1310 may provide electrical coupling toboth measurement electrodes 1306 and temperature sensor 1304.Additionally, contact electrodes 1310 and measurement electrodes 1306are electrically coupled via conductive leads 1308, according to anembodiment. Conductive leads 1308 may be hidden from the view of a userby disposing them within plastic body 1301, according to an embodiment.Conductive leads 1308 may also be used to provide electrical couplingbetween contact electrodes 1310 and temperature sensor 1304.

FIG. 3 illustrates a subsystem-level block diagram 300 of blood glucosemonitoring device 104. Subsystem diagram 300 includes, at a high level,a glucose sensing subsystem 302 and a radio transceiver subsystem 304.In an embodiment, the components of glucose sensing subsystem 302 areconfigured to measure a blood glucose level from a blood sample on atest strip placed into test strip port 206. In an embodiment, thecomponents of radio transceiver subsystem 304 are configured to receiveblood glucose measurements from glucose sensing subsystem 302, andtransmit the blood glucose measurements to networked computer 112 over awireless communications link. In an embodiment, radio transceiversubsystem 304 is further configured to receive over the wirelesscommunications link a message in response to the transmitted bloodglucose measurement. Radio transceiver subsystem 304 may include acellular radio, either CDMA or GSM, using CPRS data transmissionprotocols for communicating over the wireless communications link.

In an embodiment, a temperature sensor 306 is included within glucosesensing subsystem 302. In one embodiment, temperature sensor 306 isimplemented within the same housing or enclosure with glucose sensingsubsystem 302. In another embodiment, temperature sensor 306 isimplemented as temperature sensor 203 disposed at the end of stalk 201.In yet another embodiment, temperature sensor 306 is implemented astemperature sensor 1304 on test strip 1300.

In an embodiment, a strip detector unit 308 is also included todetermine the type of test strip inserted and to measure the currentresponse from the test strip. In one example, strip detector unit 308includes calibration data for seven (7) different test strip codes. Inan embodiment, a voltage reference 310 is applied to the test stripelectrodes during the measurement. In one example, voltage reference 310has a value of 415 mV. A microprocessor 312 controls operation ofglucose sensing subsystem 302.

A microcontroller 320 within radio transceiver subsystem 304 controlsradio transceiver subsystem 304. In one preferred embodiment,microcontroller 320 controls all of the components within both radiotransceiver subsystem 304 and glucose sensing subsystem 302. In anembodiment, level translator 414 is included to translate the voltagelevel between microprocessor 312 and microcontroller 320. In anembodiment, microcontroller 320 interfaces with numerous components suchas a SIM card 322, a speaker 334, an antenna 338, a user interface 336,and a display module 342. In an embodiment, a power switch 330 is usedto control power provided from a battery 328 to the components of device104 including a voltage detector 332 and a voltage regulator bank 340.Voltage regulator bank 340 may comprise one or more low drop out (LDO)voltage regulators, the use of which is well known to those skilled inthe art. Voltage regulator bank 340 provides stable low voltage levelsto microcontroller 320, microprocessor 312 and display module 342.Voltage regulator bank 340 also provides stable low voltage levels todisplay module 342 via a DC to DC converter 344. In an example, voltageregulator bank 340 provides voltage outputs of 3 V, 2.8 V or 1.8 V.

In an embodiment, microcontroller 320 can control the operation ofvarious components within transceiver subsystem to mitigate the effectsof heat produced by the components. For example, the heat generated froma battery charger 326 may be controlled to prevent a rise in thetemperature above a certain threshold. In an example embodiment, thetemperature substantially near battery 328 may be controlled to not risemore than two degrees Fahrenheit above ambient conditions. Controllingthe operation of battery charger 326 may involve, for example, the useof pulse-width modulation or changing the charging voltage.Alternatively, the thermal output substantially near microcontroller 320may be controlled to prevent a rise in the temperature above a certainthreshold. In an example embodiment, the temperature substantially nearmicrocontroller 320 may be controlled to not rise more than two degreesFahrenheit above ambient conditions. Controlling this temperature mayinvolve active cooling systems or changing the clock speed ofmicrocontroller 320.

Antenna 338 may be any antenna suitable for use within a standard mobilecommunications device such as a 2G cellular telephone. Examples ofantennas include, but are not limited to, patch antennas, stripantennas, ceramic antennas, dipole antennas, whip antennas, etc.

The RF radiation generated from antenna 338 may interfere with theelectrochemical measurements performed by glucose sensing subsystem 302.In an embodiment, glucose sensing subsystem 302 and radio transceiversubsystem 304 are substantially isolated within blood glucose monitoringdevice 104 in order to minimize the RF interference between the twosubsystems. The isolation may be realized by providing each subsystem onits own separate printed circuit board (PCB).

In another embodiment, RF interference may be further reduced bydisposing a shielding structure 301 around at least a portion of glucosesensing subsystem 302. In an example, shielding structure 301 surroundstemperature sensor 306, strip connector 308 and voltage reference 310.Shielding structure may alternatively be disposed around all thecomponents of glucose sensing subsystem 302. Shielding structure 301 maybe a Faraday cage which substantially attenuates external RF signals.The Faraday cage may be formed, for example, using a metallic foil.

In yet another embodiment, microcontroller 320 may deactivate RFemission from antenna 338 during a measurement time period when theelectrochemical reaction is taking place on the test strip. Once glucosesensing subsystem 302 has successfully performed the measurement fromthe sample, microcontroller 320 may reactivate the RF transmissioncircuitry coupled to antenna 338.

Components which exist external to the blood glucose monitoring deviceinclude an AC adapter 316 for providing useable current from a commonelectrical outlet, and a connector 318 for connecting AC adapter 316 toconnection port 204 of device 104. Connector 318 may be any suitableconnector that can exist between two electronic or electrical sourcesincluding, but not limited to, USB, micro USB, IEEE 1394 (Firewire),etc. In an embodiment, connector 318 may be used to link connection port204 to a computer. Connection port 204 is configured to allow current toflow to either a battery charger 326 or a voltage regulator 324.

FIG. 4 illustrates a state transition diagram 400 illustrating anexample mode of operation of blood glucose monitoring device 104according to an embodiment. The blood glucose monitoring device beginsin the power off state 402. Starting state 404 is transitioned to whenthe power button on the blood glucose monitoring device is pressed (B_P)and further transitions to an initial state 406. Initial state 406transitions to a waiting for strip state 408 without any input from thepatient.

At state 408, a message is shown on the display of blood glucosemonitoring device 104, prompting the patient to insert a test strip intothe test strip port. In an example, pressing any button (B_any)associated with the user interface of device 104 transitions from state408 to a menu state 412. In another example, state 408 transitions to anidle state 410 if no action is taken within a threshold time period. Thethreshold time period is, for example, 30 seconds. Inserting a teststrip (Strip_I) causes device 104 to transition from state 408 to samplestate 414.

At state 412, menu options are shown on the display of the blood glucosemonitoring device. State 412 transitions to state 410 if no action istaken within a threshold time period. As mentioned above, the thresholdtime period is, for example, 30 seconds. A patient may use the userinterface on the blood glucose monitoring device to prompt the device towait for a test strip (B_E) which causes a transition from state 412 tostate 408. Inserting a test strip (Strip_I) will also transition device104 from state 412 to sample state 414.

At state 410, device 104 enters an idle mode and shuts the power off tothe display in order to conserve energy. Pressing any button (B_any)associated with the user interface transitions device 104 from state 410to state 406. Inserting a test strip (Strip_I) causes device 104 totransition from state 410 to sample state 414.

At state 414, device 104 waits to receive a blood sample on the teststrip which has been placed into the test strip port. Removing the teststrip (Strip_O) before a sample has been placed on the test strip causesa transition from state 414 to state 408. State 414 transitions to state410 if no action is taken within a threshold time period. Again, thethreshold time period is, for example, 30 seconds. State 414 transitionsto sample execution state 416 once a blood sample has been placed on thetest strip (Apply_S).

At state 416, the blood glucose level is measured from the sample. Ifthe test strip is removed prior to the completion of the sampleanalysis, then state 416 transitions to a strip error state 418. If themeasurement of the blood glucose level from the sample is completed,state 416 transitions to transmission state 420.

At strip error state 418, a message is shown on the display of device104 alerting the patient that a measurement error occurred. State 418transitions to state 408 to wait for a test strip to be placed back intothe test strip port.

At state 420, the glucose measurement is transmitted to a networkedcomputer in order to be stored in a patient's record within a database.The glucose measurement is shown on the display of device 104. State 420transitions to ending state 422 when the test strip is removed(Strip_O).

The state transitions of device 104, illustrated in the exemplaryembodiment of FIG. 4, are controlled by a computer program (e.g.,software and/or firmware) residing in microprocessor 312 or,alternatively, in a memory (not shown) associated with microprocessor312.

Referring back to FIG. 1, blood-glucose measurements from a plurality ofmonitored patients are stored in a database in networked computer 112.The database can then be accessed by remote computer 114 for analysis ofthe blood-glucose measurements. For example, in connection with analysisand/or display of the blood-glucose measurements on remote computer 114,FIGS. 5-8 shows exemplary screenshots that may be shown on a displayassociated with remote computer 114. It should be understood that anytext or graphics shown are examples of possible text or graphics. Aperson skilled in the art would be capable of altering presentation ofthe blood-glucose data to achieve the same goals described hereinwithout departing from the spirit or scope of the present invention.

The exemplary screenshots displayed in FIGS. 5-8 are associated with acomputer program executed by a processor within remote computer 114.

FIG. 5 illustrates a patient data summary screen 500 displaying glucosereadings for a particular patient. The top portion of patient datasummary screen 500 displays a patient name 502 associated with therecord being shown, a date 504, a patient menu bar 506, a settingsbutton 505 and an upgrade button 507. The middle portion of patient datasummary screen 500 displays an average readings section 508, a latestreadings table 510, a reading summary 512, a reading history 514, and anaverage readings graph 516. The bottom portion of patient data summaryscreen 500 displays a latest messages section 518 and a print reportsection 520.

Date 504 may be associated with the date that the patient activatedtheir account within patient monitoring network 100. Alternatively, date504 may be associated with the last time the record had been accessed bythe patient. Any other dates of interest for the patient may bedisplayed as date 504.

Patient menu bar 506 may display icons allowing the user to navigate toother pages. For example, one icon returns the user to patient datasummary screen 500 when selected. Another icon, when selected, maynavigate a user to a friend's page allowing the user to select emailaddresses of others who would be allowed to view their record. Anothericon, when selected, may navigate a user to a profile page, which allowsthe user to change basic profile information associated with the recordsuch as the patient's name, patient's address, etc. Another icon, whenselected, may navigate a user to a support page which allows the user tocontact a technical support group for the software. Another icon, whenselected, may allow the user to log out of the software program. Patientmenu bar 506 may continue to exist at the top of the page regardless ofthe content shown on the rest of the page.

Settings button 505 may be selected to display a drop-down menuproviding various menu options. For example, menu options such asmessaging, clinical profile, or an HCP (health care provider) log may bedisplayed. The HCP log may include a list of all the dates and timesthat a licensed healthcare professional has accessed the current record.

In an embodiment, selecting the messaging menu option navigates the userto a page allowing the user to choose which default messages are sent tothe blood glucose monitoring device associated with the record. In anembodiment, default messages are sent to the blood glucose monitoringdevice in response to a blood glucose measurement being transmitted bythe device. Default messages may contain information relating the mostrecent blood glucose measurement to past measurements taken by the bloodglucose monitoring device or information relating to a completionpercentage of prescribed blood glucose measurements for the day.

In an embodiment, selecting the clinical profile menu option navigatesthe user to a patient clinical profile screen 600 exemplarilyillustrated in FIG. 6 and described in more detail below.

In an embodiment, selecting the HCP log menu option displays a listingof dates and times that the record has been accessed by a licensedhealthcare professional associated with the patient.

In an embodiment, upgrade button 507 searches the internee or anynetwork for a software upgrade to the currently running program. If asoftware upgrade is found, the program may automatically install theupgrade.

Average readings section 508 may display information regarding thestored history of blood glucose measurements taken with the bloodglucose monitoring device associated with the record. For example,information displayed may include an average blood glucose level, anaverage number of tests performed each day, or a compliance percentage.

Latest readings table 510 may display a list of blood glucose readingsin chronological order taken with the blood glucose monitoring deviceassociated with the record. In an embodiment, the most recent reading isshown at the top. In an embodiment, a side slider bar is used to scrollthrough the list of readings.

Reading summary 512 may display values of particular interest to theuser. For example, reading summary 512 may display the highest andlowest blood glucose readings taken. In another example, reading summary512 may display percentages relating to how many blood glucose readingshave had levels which were low, normal, high, or very high.

Reading history 514 may display average blood glucose readings during avariety of events. Example of events may include before and after meals,before and after exercising, before and after having a snack, etc.Reading history 514 may display averages taken over a customizable timeperiod. In an embodiment, reading history 514 may display averages takenover 7 days, 30 days, or 90 days. In an embodiment, reading history 514displays blood glucose readings for a specific day.

Average reading graph 516 displays average blood glucose readings takenover a customizable time period in any graphical format. Examples ofgraphical formats include, but are not limited to, line graphs,scatterplots, bar graphs, etc.

Received messages section 518 may display a list of the most recentmessages received by the blood glucose monitoring device associated withthe record. The messages may include any type of message includingdefault messages, personalized messages, triggered messages, or messagesalerting the patient to order more test strips. In an embodiment, thetime that the message was received is also included with each messagedisplayed.

Print report section 520 allows the user to create a printout of therecord. The record may be transferred into any suitable file format tobe printed including, but not limited to, ADOBE PDF file, .txt file,.doc file, etc. The printed record may be chosen to include glucosereading data over a certain time period. For example, the printed recordmay include glucose reading data over the past 7 days, past 30 days, orpast 90 days.

FIG. 6 displays an embodiment of patient clinical profile screen 600which may include patient name 602 and date 604 as previously described.Patient clinical profile screen 600 may also include a normal rangeinput 606, a max high value input 608, a time period 610, and agraphical slider bar 612. As illustrated in FIG. 6, patient clinicalprofile screen 600 may include a plurality of the noted elements fordifferent time periods. The various elements associated with each timeperiod may each be changed by the user separately between the differenttime periods. Patient clinical profile screen 600 may also include anupdate button 614.

The patient clinical profile allows the user to select which bloodglucose reading ranges should be considered to be low, normal, high, orvery high at various time periods throughout the day. This level ofcustomization is important since nominal blood sugar levels may varyfrom user to user depending on numerous factors such as genetics, dailyhabits, etc. Examples of time periods include before or after a meal,before or after exercising, and at night before going to sleep.

Normal range input 606 may include two text fields allowing the user toinput the range of blood glucose levels that should be considered“normal” for the given time period. Max high value input 608 may includea single text field allowing the user to input the maximum blood glucoselevel that is considered to be in the “high” range. Once all inputs havebeen entered, during the associated time period, any blood glucosemeasurement below the inputted normal range will register as a “low”reading, any measurement between the normal range will register as a“normal” reading, any measurement higher than the normal range but lowerthan the max high value will register as a “high” reading, and anymeasurement higher than the max high value will register as a “veryhigh” reading.

Graphical slider bar 612 may be shown to graphically display the variousglucose range settings for each time period 610, wherein each range isseparated by widgets 613 a-c. In an embodiment, graphical slider bar 612may be used to input the glucose ranges for each time period by slidingwidgets 613 a-c along graphical slider bar 612.

Update button 614 is used to submit the changes made to the clinicalprofile. The program returns to patient data summary screen 500 afterthe user selects update button 614.

FIG. 7 displays an embodiment of a caregiver data summary screen 700which includes a graphical summary section 702, a caregiver menu bar708, and a patient list 710. Graphical summary section 702 may furtherinclude one or more of a patient summary graph 704 along with acorresponding graph legend 706.

Caregiver data summary screen 700 is provided to assist caregivers inmonitoring a plurality of their patients, each with an associated bloodglucose monitoring device. At the top of caregiver data summary screen700, caregiver menu bar 708 may be provided to display icons which allowthe user to either navigate to other pages or to access drop down menus.For example, one icon may produce a dropdown menu containing menuoptions for the data to be displayed in graphical summary section 702.In another example, one icon may navigate the user to a page listing allof the patients that have received a referral by the logged-incaregiver. In another example, one icon may navigate the user to anadministration page, which allows the user to change their basic profileinformation, set which default messages should be sent out to allpatients, and access a script editor as will be discussed in more detailbelow. Another icon, when selected, may allow the user to log out of thesoftware program. In an embodiment, caregiver menu bar 708 may continueto exist at the top of the page regardless of the content shown on therest of the page.

Graphical summary section 702 may contain one or more graphs displayingdata relating to all of the patients under supervision of the logged-incaregiver. Examples of graphs include, but are not limited to, piegraphs, line graphs, bar graphs, scatterplots, etc. Examples of patientdata to display include age, type of diabetes, gender, state ofresidence, average blood glucose level, and compliance. In theillustrated example of FIG. 7, patient summary graph 704 is a pie chartwith corresponding graph legend 706.

Patient list 710 includes a listing of each patient associated with thelogged-in caregiver. Patient list 710 may provide various informationabout each patient including, but not limited to, phone number, type ofdiabetes, activation date, average blood glucose level, prescribednumber of daily tests, compliance percentage, most recent blood glucosereading, etc.

FIG. 8 illustrates an embodiment of a script editor 800. Script editor800 may be accessed via an administration page as previously described.In an embodiment, script editor 800 includes a personal message field801, reading threshold 802, an iteration threshold 804, a message field806, an enable checkbox 808, a delete button 810, and a save button 812.It should be noted that script editor 800 may be used to create one ormore different scripts to be executed.

Script editor 800 allows the user to make changes to scripts executed bya rules engine on networked computer 112. The scripts are executed inresponse to received blood glucose readings from a blood glucosemonitoring device and may return a triggered message if certain criteriais met. The criteria as well as the content of the triggered message maybe changed using script editor 800. Regardless of whether the criteriais met or not, the executed scripts will return any enabled defaultmessages or personalized messages to the blood glucose monitoring devicein response to a received blood glucose reading.

Reading threshold 802 may display a dropdown menu when selected. Theassociated dropdown menu may allow the user to choose between variousblood glucose reading identifiers such as, for example, “Low”, “Normal”,“High”, etc. Similarly, iteration threshold 804 may include a dropdownmenu when selected to choose a number of consecutive readings that fitthe identifier chosen in reading threshold 802. When the criteriacomprising reading threshold 802 and iteration threshold 804 are metupon receiving a blood glucose measurement, a triggered messagecomprising text entered into message field 806 is sent to the bloodglucose monitoring device.

In an embodiment, script editor 800 is used to edit the scripts for allpatients under supervision of the logged-in caregiver. In anotherembodiment, script editor 800 is used to edit different scripts for eachpatient under supervision of the logged-in caregiver.

As an example, a script for a particular patient includes readingthreshold 802 set to “Very High”, iteration threshold 804 set to “5”,and message field 806 containing the text, “You have tested very high 5straight times. Please call me!” In this example, if the particularpatient transmits a “Very High” blood glucose measurement five straighttimes using a particular blood glucose monitoring device, than thescript will produce the triggered message entered into message field 806and transmit the triggered message to the particular blood glucosemonitoring device.

Enable checkbox 808 may be used to either enable or disable theassociated script. If disabled, the triggered message will not be sentto the blood glucose monitoring device even if the criteria had beenmet. The script may be re-enabled at any time. Delete button 810 may beused to delete the associated script.

Script editor 800 also allows a user to enter a personalized messageinto personal message field 801. A personalized message may beassociated with only a particular patient. In one embodiment, thepersonalized message will be transmitted to the blood glucose monitoringdevice associated with the patient upon receiving the next blood glucosemeasurement from the blood glucose monitoring device. In anotherembodiment, the personalized message is transmitted to the blood glucosemonitoring device immediately after selecting a submit button (notshown) displayed within script editor 800.

Save button 812 may be selected by the user to save the changes made inscript editor 800. Selecting save button 812 returns the user tocaregiver data summary screen 700.

FIG. 9 illustrates an exemplary measurement method 900 performed byblood glucose monitoring device 104 after taking a blood glucosemeasurement. It should be understood that measurement method 900 can beone of many methods performed by device 104 either in parallel orsequentially.

At block 902, a measurement is performed via the glucose sensingsubsystem within the blood glucose monitoring device according to anembodiment. The glucose sensing subsystem applies a reference voltage tothe blood sample and measures a current response produced from anelectrochemical reaction on the test strip. The measured current iscompared to a calibration curve and is translated into a voltage, themagnitude of which corresponds to the glucose level in the sample.

At block 904, the voltage calculated at block 902 is sent to the radiotransceiver subsystem within the blood glucose monitoring device. Theradio transceiver subsystem generates a signal which is modulated by thevoltage.

At block 906, the signal which has been modulated by the voltage iswirelessly transmitted to a networked computer. The signal may beencrypted by the radio transceiver subsystem prior to transmission. Anyencryption technique known to those skilled in the art may be utilizedincluding, but not limited to, two-factor authentication, 128-bitencryption, etc. The signal received by the networked computer may bedecrypted by the networked computer, and the data relating to the bloodglucose measurement may be stored in a record within a database on thenetworked computer.

At block 908, one or more messages returned from the networked computerare received by the radio transceiver subsystem in response to themeasurement transmission at block 906. The one or more messages mayinclude any of the message types previously described including defaultmessages, triggered messages, personalized messages, or a low-supplymessage alerting the user to purchase more test strips. The low-supplyalert may include an offer to purchase strips. Further, a user/patientmay place an order by responding to the low-supply message via device104. Networked computer may be configured to receive the order and toinitiate a business process that will result in fulfillment of theorder, including shipping the ordered test strips to the user/patientassociated with the particular device 104 from which the order wasplaced. In addition to ordering test strips, the networked computer maysend a message to device 104 that includes an offer to order relatedsupplies for use with the particular device. Still further, the user maybe prompted or provided with an offer to order other merchandise relatedto his/her needs but not necessarily related to any medical condition.

FIG. 10 describes an exemplary server method 1000 performed by anetworked computer upon receiving a glucose measurement from a bloodglucose monitoring device. It should be understood that server method1000 can be one of many methods performed by a networked computer eitherin parallel or sequentially.

At block 1002, a blood glucose measurement sent from the blood glucosemonitoring device is received by the networked computer. The receivedsignal is demodulated/decoded to retrieve for analysis the data relatingto the measured blood glucose level.

At block 1004, the retrieved blood glucose level is stored in a recordof a database. Each record corresponds to a unique blood glucosemonitoring device. The records may be accessed by a remote computer andgraphically displayed through a software program executed by a processoron either the networked computer or the remote computer.

At block 1006, at least one script is executed to produce one or moremessages to be returned to the blood glucose monitoring device. In anexample, a script may be executed to compare past measurements anddetermine whether a triggered message should be sent. In anotherexample, a script may be executed to produce a personalized message. Inanother example, a script may be executed to track the number of teststrips remaining associated with the blood glucose monitoring device. Ifthe number of test strips is below a certain threshold, a low supplymessage is produced alerting the patient associated with the bloodglucose monitoring device that they are running low on supplies. Asdiscussed above, the networked computer may transmit an offer to ordermore test strips (or other merchandise), if the number of test strips isbelow a certain threshold. It should be understood that after allscripts have been executed, a message may not necessarily be producedand returned to the transmitting device 104.

At block 1008, the networked computer determines whether the criteriahave been met to send a triggered message.

At block 1010, the criteria associated with one or more triggeredmessages has been met. The one or more triggered messages along with anydefault messages, personalized messages, or low supply messages aretransmitted to the blood glucose monitoring device.

At block 1012, the criteria associated with any triggered message hasnot been met. Any default messages, personalized messages, or low supplymessages are transmitted to the blood glucose monitoring device.

FIG. 11 describes an exemplary received message method 1100 performed byblood glucose monitoring device 104. It should be understood thatreceived message method 1100 can be one of many methods performed by theblood glucose monitoring device either in parallel or sequentially.

At block 1102, one or more messages are received by the radiotransceiver subsystem within blood glucose monitoring device 104.

At block 1104, the one or more messages are sent to the display of bloodglucose monitoring device 104. The messages may be displayed in anysuitable format, such as one at time, allowing the user to scrollthrough them, or concatenated together into one message, etc.

In an alternate embodiment, the monitoring system of the invention canbe used to monitor other analytes. For, example, the blood glucosesensor may be replaced with a sensor to monitor interstitial fluidglucose, blood coagulation factors, cardiac enzymes, catecholamines, andother biomarkers. Such alternate sensors may operate, for example, usingelectrochemical or colorimetric sensing techniques as would be apparentto a person skilled in the relevant art.

In this alternate embodiment, the analyte monitoring system comprising ahandheld analyte monitoring device and a networked computer. Similar tothe blood glucose monitoring device, the analyte monitoring deviceincludes an analyte sensing subsystem configured to measure an analytefrom a patient, and a radio transceiver subsystem configured to receiveanalyte measurements from the analyte sensing subsystem and to transmitthe analyte measurements over a wireless communications link. Similar tothe blood glucose monitoring system, the networked computer isconfigured to receive the transmitted analyte measurements. A rulesengine running on the networked computer is configured to execute atleast one script in response to a received analyte measurement and toproduce a message to be sent back to the handheld analyte monitoringdevice.

In this alternate embodiment, the networked computer includes a databasecontaining records corresponding to each one of a plurality of handheldanalyte monitoring devices. Each database record identifies a pluralityof messages personalized to a user associated with a particular handheldanalyte monitoring device. Message sent back to the handheld analytemonitoring device is selected from the plurality of messages using thescript executed by the rules engine.

In yet another alternate embodiment, the monitoring system of theinvention can be used to monitor other medical information including,for example, physiologic parameters such as heart rate, blood oxygensaturation, blood pressure, respiration rate, blood pressure,electrocardiographic (ECG) information including ECG morphology using asensor in communication with an implantable cardioverter defibrillator,body temperature, and the like. Sensors for such physiologic parametersare known in the art and are commercially available.

Various aspects of the present invention can be implemented by software,firmware, hardware, or a combination thereof. FIG. 12 illustrates anexample computer system 1200 in which the embodiments, or portionsthereof, can be implemented as computer-readable code. For example,networked computer 112 carrying out method 1000 of FIG. 10 can beimplemented in system 1200. Various embodiments of the invention aredescribed in terms of this example computer system 1200. As anotherexample, remote computer 114 can be implemented in a computer systemsuch as system 1200.

Computer system 1200 includes one or more processors, such as processor1204. Processor can be a special purpose or a general purpose processor.Processor 1204 is connected to a communication infrastructure 1206 (forexample, a bus or network).

Computer system 1200 also includes a main memory 1208, preferably randomaccess memory (RAM), and may also include a secondary memory 1210.Secondary memory 1210 may include, for example, a hard disk drive and/ora removable storage drive. Removable storage drive 1214 may include afloppy disk drive, a magnetic tape drive, an optical disk drive, a flashmemory, or the like. The removable storage drive 1214 reads from and/orwrites to removable storage unit 1218 in a well-known manner. Removablestorage unit 1218 may include a floppy disk, magnetic tape, opticaldisk, etc. which is read by and written to by removable storage drive1214. As will be appreciated by persons skilled in the relevant art(s),removable storage unit 1218 includes a computer usable storage mediumhaving stored therein computer software and/or data.

In alternative implementations, secondary memory 1210 may include othermeans for allowing computer programs or other instructions to be loadedinto computer system 1200. Such means may include, for example, aremovable storage unit 1222 and an interface 1220. Examples of suchmeans may include a program cartridge and cartridge interface (such asthat found in video game devices), a removable memory chip (such as anEPROM, or PROM) and associated socket, and other removable storage units1222 and interfaces 1220 which allow software and data to be transferredfrom the removable storage unit 1222 to computer system 1200.

Computer system 1200 also includes a communications interface 1224.Communications interface 1224 allows software and data to be transferredbetween computer system 1200 and external devices. Communicationsinterface 1224 may include a modem, a network interface (such as anEthernet card), a communications port, a PCMCIA slot and card, or thelike. Software and data transferred via communications interface 1224are in the form of signals which may be electronic, electromagnetic,optical, or other signals capable of being received by communicationsinterface 1224. These signals are provided to communications interface1224 via a communications path 1226. Communications path 1226 carriessignals and may be implemented using wire or cable, fiber optics, aphone line, a cellular phone link, an RF link or other communicationschannels. For example, communications path 1226 may correspond tocommunications link 110 and/or communications link 116. In this example,links 110 and 116 may be networks connected to the global Internet, andcommunications interface 1224 may be a network card configured toreceive TCP/IP-based communications from such networks.

In this document, the term “computer readable storage medium” is used togenerally refer to media such as removable storage unit 1218, removablestorage unit 1222, and a hard disk installed in hard disk drive 1212.Computer readable storage medium can also refer to one or more memories,such as main memory 1208 and secondary memory 1210, which can be memorysemiconductors (e.g. DRAMs, etc.). These computer program products aremeans for providing software to computer system 1200.

Computer programs (also called computer control logic) are stored inmain memory 1208 and/or secondary memory 1210. Computer programs mayalso be received via communications interface 1224. Such computerprograms, when executed, enable computer system 1200 to implement theembodiments as discussed herein. In particular, the computer programs,when executed, enable processor 1204 to implement the processes ofembodiments of the present invention, such as the steps in the methodsdiscussed above. Accordingly, such computer programs representcontrollers of the computer system 1200. Where embodiments areimplemented using software, the software may be stored in a computerprogram product and loaded into computer system 1200 using removablestorage drive 1214, interface 1220, or hard drive 1212.

Embodiments may be directed to computer products comprising softwarestored on any computer usable medium. Such software, when executed inone or more data processing device, causes a data processing device(s)to operate as described herein.

Embodiments may be implemented in hardware, software, firmware, or acombination thereof. Embodiments may be implemented via a set ofprograms running in parallel on multiple machines.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

The present invention has been described above with the aid offunctional building blocks illustrating the implementation of specifiedfunctions and relationships thereof. The boundaries of these functionalbuilding blocks have been arbitrarily defined herein for the convenienceof the description. Alternate boundaries can be defined so long as thespecified functions and relationships thereof are appropriatelyperformed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

What is claimed is:
 1. A handheld blood glucose monitoring devicecomprising: a glucose sensing subsystem configured to measure a bloodglucose level in a blood sample; a temperature sensor configured toprovide a temperature measurement during the measurement of the bloodglucose level; a radio transceiver subsystem electrically isolated fromthe glucose sensing subsystem and configured to receive the measuredblood glucose level from the glucose sensing subsystem, and to transmitthe measured blood glucose level over a wireless communications link;and a display configured to display the measured blood glucose level,wherein the radio transceiver subsystem includes a microcontrollerconfigured to monitor and control the amount of heat produced by one ormore components within the radio transceiver subsystem.
 2. The device ofclaim 1, further comprising an RF shielding structure around at least aportion of the glucose sensing subsystem.
 3. The device of claim 1,wherein the microcontroller is further configured to deactivate RFtransmission from the radio transceiver subsystem when the glucosesensing subsystem is measuring the blood glucose level.
 4. The device ofclaim 1, wherein the temperature sensor is disposed in a thermallysegregated portion of the handheld blood glucose monitoring device.
 5. Ahandheld analyte monitoring device comprising: an analyte sensingsubsystem configured to measure a level of an analyte from a user; atemperature sensor configured to provide a temperature measurementduring the measurement of the analyte level; a radio transceiversubsystem electrically isolated from the analyte sensing subsystem andconfigured to receive the measured analyte level from the analytesensing subsystem, and to transmit the measured analyte level over awireless communications link; and a display configured to display themeasured analyte level, wherein the radio transceiver subsystem includesa microcontroller configured to monitor and control the amount of heatproduced by one or more components within the radio transceiversubsystem.
 6. The device of claim 5, further comprising an RF shieldingstructure around at least a portion of the analyte sensing subsystem. 7.The device of claim 5, wherein the microcontroller is further configuredto deactivate RF transmission from the radio transceiver subsystem whenthe analyte sensing subsystem is measuring the analyte level.
 8. Thedevice of claim 5, wherein the temperature sensor is disposed in athermally segregated portion of the handheld analyte monitoring device.9. The device of claim 5, wherein the analyte is glucose.